Our Pharmacovigilance services ensure drug safety through
regulatory compliance, risk management, and advanced signal detection. We streamline
adverse event reporting, case processing, and audit readiness, leveraging automation
and AI to enhance efficiency, minimize risks, and maintain global safety standards
throughout the product lifecycle.
Safety System Implementation
Deploying state-of-the-art
pharmacovigilance systems to streamline adverse event reporting, case processing,
and regulatory submissions while ensuring compliance with global safety standards.
Data Migration
Facilitating seamless and secure migration of critical
pharmacovigilance data between legacy and modern platforms, preserving data
integrity and regulatory compliance.
PV Analytics and Signal Detection
Leveraging AI-driven analytics to detect potential safety concerns
early, assess drug safety trends, and implement proactive risk management
strategies.
Audit and Inspection Readiness
Preparing organizations for stringent regulatory audits through
mock inspections, gap analysis, and corrective action planning to ensure adherence
to compliance requirements.
Computer System Validation (CSV)
Ensuring that pharmacovigilance software and electronic systems meet
regulatory and operational requirements, maintaining data accuracy, reliability, and
security.
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Tracking and managing adverse drug reactions for patient safety.
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Ensuring adherence to global pharmacovigilance regulations and guidelines.
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Identifying and mitigating potential drug-related safety risks